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Abstract: South Africa’s efforts to reform its intellectual property (IP) regime in order to improve access to medicines has sparked a firestorm lately, with major pharmaceutical companies openly at odds with civil society and developing countries.

South Africa’s efforts to reform its intellectual property (IP) regime in order to improve access to medicines sparked a firestorm in January 2014, with major pharmaceutical companies openly at odds with civil society and developing countries

The draft IP policy was published in September 2013, with the country currently taking steps toward its eventual implementation. The changes would establish a system of substantive patent examination, and would also strengthen the existing criteria for “patentability.” These revisions, proponents say, would make it easier for generic drugs to compete in a market that has long been dominated by the research-based pharmaceutical industry.

“The current system allows pharmaceutical companies to obtain multiple patents on the same drug, even for inventions that do not fall under the country’s definition of innovation,” various civil society organisations have said in advocating for the reform.

The existing regime, they added, thus allows these companies to extend their monopolies and charge inflated prices for medicines, while making it difficult for generic manufacturers to compete.

However, the leak soon thereafter of a memo aimed at helping major drug companies undermine the proposed change has escalated the row, with South African Health Minister Aaron Motsoaledi openly comparing the industry campaign to “genocide.”

Civil society, developing countries weigh in

Several developing countries, along with a coalition of civil society groups, have spoken up in support of South Africa, during a meeting of the World Health Organization’s (WHO) Executive Board end of January, 2014.

The industry response is “unacceptable in a country facing one of the world’s most acute HIV and [tuberculosis] epidemics,” Médecins Sans Frontières said at the meeting, noting that medicine prices in South Africa are up to 35 times higher than in countries where generics have a greater market share.

Some civil society organisations have formally called on the WHO Executive Board to adopt a resolution expressing solidarity with the African country.

WHO Director -General Margaret Chan has similarly expressed her concern, saying that “no government should be intimidated by interested parties for doing the right thing in public health.”

Public health and access to medicine is believed to have been greatly affected by the international agreement on TRIPS instituted at the Uruguay Round in 1994.

The WTOs main agreement on IP, which offers intellectual property protection to drug discoveries and innovations, has been a source of contention between pharmaceuticals and Non-governmentals in the public health circles.

Delegates meeting at the World Intellectual Property Organization (WIPO) last week made some limited progress in discussions on genetic resources and intellectual property rights, producing a new streamlined draft text to forward to the organisation’s General Assembly in September.

However, the new document still contains many brackets on a range of important subjects.

These discussions are held under WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), which aims to develop an international legal instrument(s) that would protect genetic resources, traditional knowledge, and traditional cultural expressions.

Problematic disclosure

One of the provisions that sparked the most debate last week was on the mandatory disclosure of the origin of genetic material used by patent applicants, or on which they seek patent claims.

While developing countries say that the requirement is essential for preventing biopiracy, some developed countries and industry groups argue that it could disincentivise innovation and be burdensome on patent offices and applicants.

According to the draft text, which still contains brackets in this area, each party shall require applicants to disclose the country of origin and source of the genetic resources and associated traditional knowledge. However, new language has also been introduced to the effect that patent offices must provide sufficient effective guidance to applicants on how to meet disclosure requirements.

The range of post-grant sanctions for non-compliance with the disclosure requirement and whether these include patent revocation remains unresolved.

Misappropriation

The IGC also identified “preventing misappropriation of genetic resources and associated traditional knowledge” as the main policy objective of the proposed international instrument. For many years, developed countries had been reluctant to accept this concept as the key goal behind the WIPO discussions.

The widely-deliberated definition currently includes a US proposal that outlines what would not qualify as misappropriation - namely, any genetic resources and their associated traditional knowledge that have been attained lawfully. Some examples, they say, could include reading publications, reverse engineering, and inadvertent disclosure.

Another IGC meeting is scheduled for July, in the hopes of bridging the remaining differences before the General Assembly.